Nomegestrol / Estradiol Formulation

Organon & Co

Revision date : 2024-04-06

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GHS08 GHS09
Health risk rating 5
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

>=10-<20

EC/CAS

14807-96-6

Name of the chemical

Talc

Concentration

>=1-<10

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

>=0.1-<1

General Information

Version

9.2

Revision date

2024-04-06

Product name

Nomegestrol / Estradiol Formulation

1.2.1 Relevant identified uses

Pharmaceutical

Emergency telephone

+1-215-631-6999

Icons in SDS

GHS08 GHS09 M004 M009 M010 M011 M017

Company Information

company name

Organon & Co

e-mail address of the competent person responsible for the Safety Data Sheet

EHSSTEWARD@organon.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H350, H360FD, H372, H410

Hazard statements

Code

Statements

H350

May cause cancer

Section 2

SECTION 2: Hazards identification

GHS Classification Carcinogenicity Category 1 Reproductive toxicity Category 1 Specific target organ toxicity - Category 1 (Liver, Bone, Blood, Endocrine system) repeated exposure Hazardous to the aquatic Category 1 environment - chronic hazard

Signal word

Danger

Hazard statements

H350 May cause cancer. H360FD May damage fertility. May damage the unborn child. H372 Causes damage to organs (Liver, Bone, Blood, Endo- crine system) through prolonged or repeated exposure. H410 Very toxic to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.

Response

P308 + P313 IF exposed or concerned: Get medical advice/ attention. P391 Collect spillage.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/ container to an approved waste disposal plant.

Other hazards which do not result in classification

Dust contact with the eyes can lead to mechanical irritation. Contact with dust can cause mechanical irritation or drying of the skin. May form explosive dust-air mixture during processing, handling or other means.

2.1 Classification of the substance or mixture

Carcinogenicity : Category 1 Reproductive toxicity : Category 1 Specific target organ toxicity - : Category 1 (Liver, Bone, Blood, Endocrine system) repeated exposure Hazardous to the aquatic : Category 1 environment - chronic hazard

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